PMID- 35549733 OWN - NLM STAT- MEDLINE DCOM- 20230710 LR - 20230717 IS - 1932-2968 (Electronic) IS - 1932-2968 (Linking) VI - 17 IP - 4 DP - 2023 Jul TI - First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America. PG - 1008-1015 LID - 10.1177/19322968221096162 [doi] AB - BACKGROUND: The first two studies of an artificial pancreas (AP) system carried out in Latin America took place in 2016 (phase 1) and 2017 (phase 2). They evaluated a hybrid algorithm from the University of Virginia (UVA) and the automatic regulation of glucose (ARG) algorithm in an inpatient setting using an AP platform developed by the UVA. The ARG algorithm does not require carbohydrate (CHO) counting and does not deliver meal priming insulin boluses. Here, the first outpatient trial of the ARG algorithm using an own AP platform and doubling the duration of previous phases is presented. METHOD: Phase 3 involved the evaluation of the ARG algorithm in five adult participants (n = 5) during 72 hours of closed-loop (CL) and 72 hours of open-loop (OL) control in an outpatient setting. This trial was performed with an own AP and remote monitoring platform developed from open-source resources, called InsuMate. The meals tested ranged its CHO content from 38 to 120 g and included challenging meals like pasta. Also, the participants performed mild exercise (3-5 km walks) daily. The clinical trial is registered in ClinicalTrials.gov with identifier: NCT04793165. RESULTS: The ARG algorithm showed an improvement in the time in hyperglycemia (52.2% [16.3%] OL vs 48.0% [15.4%] CL), time in range (46.9% [15.6%] OL vs 50.9% [14.4%] CL), and mean glucose (188.9 [25.5] mg/dl OL vs 186.2 [24.7] mg/dl CL) compared with the OL therapy. No severe hyperglycemia or hypoglycemia episodes occurred during the trial. The InsuMate platform achieved an average of more than 95% of the time in CL. CONCLUSION: The results obtained demonstrated the feasibility of outpatient full CL regulation of glucose levels involving the ARG algorithm and the InsuMate platform. FAU - Garelli, Fabricio AU - Garelli F AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. FAU - Fushimi, Emilia AU - Fushimi E AUID- ORCID: 0000-0001-5820-3108 AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. FAU - Rosales, Nicolas AU - Rosales N AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. FAU - Arambarri, Delfina AU - Arambarri D AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. FAU - Mendoza, Leandro AU - Mendoza L AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. FAU - Serafini, Maria Cecilia AU - Serafini MC AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. AD - Comision de Investigaciones Cientificas de la Provincia de Buenos Aires, Buenos Aires, Argentina. FAU - Moscoso-Vasquez, Marcela AU - Moscoso-Vasquez M AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. AD - Instituto Tecnologico de Buenos Aires, Buenos Aires, Argentina. FAU - Stasi, Marianela AU - Stasi M AD - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. FAU - Duette, Patricia AU - Duette P AD - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. FAU - Garcia-Arabehety, Julia AU - Garcia-Arabehety J AD - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. FAU - Giunta, Javier Nicolas AU - Giunta JN AD - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. FAU - De Battista, Hernan AU - De Battista H AD - Grupo de Control Aplicado, Instituto LEICI (UNLP-CONICET), Facultad de Ingenieria, Universidad Nacional de La Plata, La Plata, Argentina. AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. FAU - Sanchez-Pena, Ricardo AU - Sanchez-Pena R AUID- ORCID: 0000-0001-9190-2576 AD - Consejo Nacional de Investigaciones Cientificas y Tecnicas, Argentina. AD - Instituto Tecnologico de Buenos Aires, Buenos Aires, Argentina. FAU - Grosembacher, Luis AU - Grosembacher L AD - Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. LA - eng SI - ClinicalTrials.gov/NCT04793165 PT - Clinical Trial PT - Journal Article DEP - 20220512 PL - United States TA - J Diabetes Sci Technol JT - Journal of diabetes science and technology JID - 101306166 RN - 0 (Blood Glucose) RN - IY9XDZ35W2 (Glucose) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) SB - IM MH - Adult MH - Humans MH - Algorithms MH - Blood Glucose MH - Blood Glucose Self-Monitoring MH - *Diabetes Mellitus, Type 1/drug therapy MH - Glucose MH - *Hyperglycemia/drug therapy MH - Hypoglycemic Agents MH - Insulin MH - Insulin Infusion Systems MH - Outpatients MH - *Pancreas, Artificial MH - South America PMC - PMC10348001 OTO - NOTNLM OT - artificial pancreas OT - artificial pancreas platform OT - clinical trial OT - closed-loop control COIS- The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2022/05/14 06:00 MHDA- 2023/07/03 06:42 PMCR- 2023/05/12 CRDT- 2022/05/13 12:04 PHST- 2023/07/03 06:42 [medline] PHST- 2022/05/14 06:00 [pubmed] PHST- 2022/05/13 12:04 [entrez] PHST- 2023/05/12 00:00 [pmc-release] AID - 10.1177_19322968221096162 [pii] AID - 10.1177/19322968221096162 [doi] PST - ppublish SO - J Diabetes Sci Technol. 2023 Jul;17(4):1008-1015. doi: 10.1177/19322968221096162. Epub 2022 May 12.